The FDA has published the draft guidance for industry titled “Determining Whether to Submit an ANDA or 505(b)(2) Application.” This guidance assists applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) described in sections 505(j) and 505(b)(2) is appropriate for the submission of a marketing application for a human drug product to FDA.
This draft guidance assists applicants by highlighting the criteria for submitting applications under section 505(j) and section 505(b)(2), identifying considerations to help applicants determine whether an application would be more appropriately submitted under either pathway, and providing direction to applicants on requesting assistance in making this determination. This draft guidance provides recommendations on the topics covered in the May 2019 guidance of the same title, as well as additional recommendations on duplicates and eligibility for approval under section 505(j) of the FD&C Act and other updates to clarify FDA’s recommendations. When finalized, this guidance will replace the May 2019 guidance and will represent FDA’s current thinking on this topic.
FDA is issuing this guidance as part of our Drug Competition Action Plan, which seeks to improve the efficiency of the generic drug development, review, and approval process.
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